Food and Drug Administration

Jason Reed/Reuters

News about Food and Drug Administration, including commentary and archival articles published in The New York Times.

Chronology of Coverage

Feb. 26, 2015

Dr Stephen Ostroff of Food and Drug Administration says agency did not review manufacturers' data on procedures necessary to clean duodenoscopes that recently infected seven patients with drug-resistant bacteria at Ronald Reagan UCLA Medical Center; reports that FDA has now asked device makers to show evidence that their recommended disinfection methods work. MORE

Feb. 25, 2015

Some critics say drug maker Shire is going too far in its marketing of Vyvanse, amphetamine-based drug that was recently approved to treat binge-eating disorder; Shire spent years before approval shaping public perception and diagnosis of binge-eating disorder, much as it did with ADHD in the past; controversy highlights marketing strategy that has yielded billions in profits and that many say presents public danger. MORE

Feb. 20, 2015

Food and Drug Admin issues alert concerning difficult-to-clean medical scopes that may be infecting patients with drug-resistant bacteria after they are inserted down throats; follows report of two patient deaths in California; alert highlights growing medical concern about superbug known as CRE, which is resistant to even last-resort antibiotics and could prove a public health hazard were it to spread from hospitals. MORE

Feb. 20, 2015

Food and Drug Administration approves 23andMe test for prospective parents to see if they carry mutations that could cause rare disease called Bloom syndrome in their children. MORE

Feb. 12, 2015

Editorial hails Food and Drug Administration's proposed simplified process for doctors to get experimental drugs for critically ill patients; holds their patients suffering life-threatening illnesses can only benefit from plan. MORE

Feb. 8, 2015

Examination of case in which OtisMed Corp illegally marketed and sold 18,000 of its OtisKnee surgical guides without Food and Drug Admin approval highlights how easily serious lapses can occur in the rapidly evolving world of medical devices; case, which resulted in an $80 million settlement, would likely not have been brought to light without key whistle-blower. MORE

Feb. 6, 2015

Food and Drug Administration Commissioner Dr Margaret Hamburg will step down following six-year tenure leading agency through some significant and challenging issues in public health; Hamburg grappled with painkiller abuse, obesity and the rise of electronic cigarettes, and received both praise and criticism for speeding up the approval of medicines. MORE

Feb. 4, 2015

Feb. 3, 2015

Institute for Safe Medication Practices study finds only about 50 percent of reports of dangerous side effects submitted by drug makers meet basic standards for completeness; Food and Drug Administration uses information to track problems with medications once they enter marketplace. MORE

Jan. 19, 2015

Op-Ed article by American Enterprise Institute scholar Sally Satel holds that success of electronic cigarettes, safer alternative to tobacco smoking, is being hindered by Food and Drug Administration's delay in regulating product; urges administration to set interim safety guidelines to assuage public concerns, rather than relying on burdensome regulation process. MORE

Jan. 16, 2015

Food and Drug Admin opens investigation into case in which hundreds of dummy intravenous saline solution bags were given to real patients; bags of unsterilized solution, intended for use in training health care workers, have lead to one death and at least 17 cases of illness; investigation follows decision by manufacturer Wallcur to recall the bags. MORE

Jan. 15, 2015

Jan. 15, 2015

Food and Drug Administration says one person died and many others were sickened after infusions of non-sterile saline solution made by San Diego-based company Wallcur; cases have been reported in seven states. MORE

Jan. 11, 2015

Several states have passed Right to Try laws, which allow critically ill patients right to try medications that have not been approved by Food and Drug Administration; some physicians oppose laws, saying they and experimental drugs are more likely to harm than help critically ill patients. MORE

Jan. 8, 2015

Food and Drug Administration panel recommends approval of EP2006, more affordable version of cancer therapy drug Neupogen, also called filgrastim; if FDA acts on recommendation it will create era of competition for so-called biologic drugs, which are made out of living cells rather than synthesized from chemicals. MORE

Jan. 6, 2015

Food and Drug Administration questions safety of giving adult laxative Miralax to children, practice routinely recommended by doctors; agency has assigned team of scientists to examine active ingredient in laxative and has disclosed discovery of trace amounts of potential toxins. MORE

Dec. 24, 2014

Food and Drug Administration says it will end decades-old lifetime prohibition on blood donation by gay and bisexual men, but will continue to not allow donations by men who have had sex with other men in the last year; ban was enacted in 1983, early in the AIDS epidemic, when testing was slower and less refined; men's health advocates welcome move as long overdue, but say stipulation still perpetuates discrimination and severely limits pool of donors. MORE

Dec. 24, 2014

Food and Drug Administration approves Novo Nordisk diabetes drug liraglutide as a treatment for obesity, first injectable drug approved for weight loss; drug will be marketed under brand name Saxenda. MORE

Dec. 17, 2014

Food and Drug Administration approves Intercept Blood System by Cerus, which could provide additional safety step beyond testing to ensure donated blood and plasma are not tainted by harmful viruses or bacteria; cautions system is not foolproof, but works well against HIV, hepatitis B and C, West Nile and many bacteria MORE

Dec. 11, 2014

Merck receives Food and Drug Administration approval for updated version of its Gardasil vaccine, which protects against human papillomavirus. MORE

Dec. 5, 2014

Editorial warns Food and Drug Administration that softer warning labels on smokeless tobacco products, which has been requested by Swedish Match, may only lure more people into the nicotine market; contends that link between smokeless tobacco products like Swedish Match's gum and lower rates of smoking and tobacco-related diseases is unclear. MORE

Dec. 4, 2014

Food and Drug Administration updates system of how drug companies must explain dangers of taking medicine during pregnancy and while breast-feeding; doctors say current system, developed in 1970s and using letters of alphabet to indicate levels of risk, is too vague. MORE

Nov. 30, 2014

Swedish Match, tobacco company that manufacturers oral 'snus' packets, has filed petition with the Food and Drug Administration to declare its smokeless product less harmful than cigarettes; circumstance raises question of whether warning labels on tobacco products should take into account varying degrees of risk (Series: The New Smoke). MORE

Nov. 28, 2014

Editorial calls for end to Food and Drug Administration rule barring homosexuals from donating blood; holds antiquated rule is holdover from days when HIV and AIDS were not fully understood; contends FDA should adopt policy that conforms with medical research. MORE

Nov. 27, 2014

Editorial praises breadth of Food and Drug Administration's list of food items and establishments included in new regulations for posting calorie counts on menus and vending machines; maintains FDA's decisions on which retailers to include in final rules are reasonable burdens for establishments, and rightly prioritize protection of the American public in critical battle against obesity epidemic. MORE

Nov. 26, 2014

Panel of medical experts advises against Food and Drug Administration putting its toughest warning on steroid injections for neck and back pain, which millions of Americans receive annually; assets that alert would have signaled to doctors that risks outweigh potential benefits. MORE

Nov. 25, 2014

Food and Drug Administration is set to release new regulations to require chain restaurants, movie theaters and pizza parlors to post calorie counts on their menus; rules are effort to address nation's obesity epidemic and will have broad implications for public health. MORE

Nov. 25, 2014

Food and Drug Administration warns against use of laparoscopic power morcellators, devices used during uterine surgery that cuts tissue to be removed into pieces, arguing that it risks spreading cancerous tissue; does not take device off market or ban it outright, but critics complain that action does not go far enough. MORE

Nov. 21, 2014

Food and Drug Administration approves long-acting opioid painkiller called Hysingla that contains pure hydrocodone; some addiction experts fear powerful narcotic will be abused but drug cannot be easily crushed or broken by addicts looking to snort or inject it. MORE

Nov. 15, 2014

Food and Drug Administration expects to receive long-delayed visas soon for employees bound for its China offices; is trying to expand its presence in China, but China has held up visas for nearly a year. MORE

Nov. 15, 2014

Swiss drug maker Roche announces that Food and Drug Administration has approved its drug Avastin as treatment for ovarian cancer. MORE

Oct. 30, 2014

Food and Drug Administration approves vaccine for dangerous strain of meningitis that caused outbreaks in 2013 at Princeton and the University of California, Santa Barbara; vaccine, manufactured by Pfizer, is to be called Trumenba. MORE

Oct. 16, 2014

Drugs Esbriet from Roche and Ofey from Boehringer Ingelheim win approval from Food and Drug Administration, and are the first that can slow progression of idiopathic pulmonary fibrosis; FDA approval could open new era for patients but also a new chapter in controversy over high drug prices. MORE

Oct. 11, 2014

Gilead Sciences' hepatitis C drug Harvoni wins approval from Food and Drug Administration; treatment is first for the disease that requires only a once-a-day pill. MORE

Oct. 3, 2014

Food and Drug Administration, in annual report, says amount of medically important antibiotics sold for use in animals raised for meat grew by 16 percent from 2009 to 2012, a pattern it says is troubling. MORE

Sep. 19, 2014

Food and Drug Administration approves Trulicity, new injectable drug for Type 2 diabetes developed by Eli Lilly. MORE

Sep. 18, 2014

Expert panel votes for Food and Drug Administration to impose strict new limitations on multibillion-dollar testosterone drug industry; recommends agency tighten labels for medicines so they are not prescribed to men who only have problems related to aging; new rules could reduce coverage from insurance companies for their use. MORE

Sep. 11, 2014

Food and Drug Administration approves Contrave, third new prescription drug for obesity since 2012, developed by Orexigen Therapeutics; drug will be marketed by Takeda Pharmaceutical of Japan. MORE

Sep. 6, 2014

Food and Drug Administration gives drug maker Keryx Biopharmaceuticals approval in United States for its ferric citrate drug to treat kidney disease complications, but clearance requires unexpected safety warnings. MORE

Sep. 5, 2014

Food and Drug Administration approves Keytruda, first of eagerly awaited new class of cancer drugs that unleashes the body's immune system to fight tumors; manufactured by Merck, drug is approved for patients with advanced melanoma who have exhausted other therapies. MORE

Aug. 16, 2014

Both World Health Organization and United States Food and Drug Administration have issued strong warnings about dietary supplements falsely marketed as Ebola cures; neither agency listed products or companies they accused of fraud or explained why they had acted so suddenly. MORE

Aug. 16, 2014

Food and Drug Administration approves Avastin, drug made by Genentech, for use against late-stage cervical cancer; approval marks seventh approved use for biotech drug. MORE

Aug. 12, 2014

Food and Drug Administration approves first screening test for colon cancer that uses patients’ DNA to help spot potentially deadly tumors and growths. MORE

Aug. 9, 2014

Editorial criticizes cost-benefit analysis that is among important criteria for proposed Food and Drug Administration rule to regulate electronic cigarettes, cigars and other tobacco products; calls analysis, which takes into account loss of pleasure smokers experience when they quit smoking, misguided if not absurd, and calls for approach to be abandoned before issuing final rule. MORE

Aug. 8, 2014

Food and Drug Administration is permitting second experimental drug from Tekmira Pharmaceuticals to be tried by people in Africa stricken with Ebola virus; it had halted trial because side effects were observed. MORE

Aug. 7, 2014

Cost-benefit analysis for smoking, embedded in federal government's new tobacco regulations, assumes that benefits from reducing smoking have to be discounted by 70 percent to offset loss in pleasure that smokers suffer when kicking their habit; experts say calculation wipes out most of economic benefits from regulations and could make them far more vulnerable to legal challenges from the tobacco industry. MORE

Aug. 1, 2014

Food and Drug Administration will start regulating medical laboratory testing, move fiercely opposed by some laboratories and pathologists, who say it will increase cost and time needed to develop tests, stifling innovation and depriving patients of some critical tools; FDA will phase in the requirements over nine years and will focus on tests that involve highest level of risk to patients. MORE

Jul. 31, 2014

Op-Ed article by food writer Ruth Reichl decries federal appeals court ruling allowing Food and Drug Administration to leave antibiotic used in animal feed on market even if it is dangerous to humans; warns that practice breeds antibiotic-resistant bacteria and notes that some mainstream food suppliers have already moved away from such antibiotics, urging entire industry to join them. MORE

Jul. 9, 2014

Six sealed vials of smallpox virus, appearing to date from 1950s, are discovered in storeroom in a Food and Drug Administration lab in Bethesda, Md; officials report no exposure risk to lab personnel or public, and vials will be safely destroyed once testing is concluded. MORE

Jun. 28, 2014

Food and Drug Administration approves Afrezza, form of insulin that is inhaled rather than injected, developed by MannKind Corporation. MORE

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Nathan Myhrvold, the Mad Hatter of modernist cooking, invited the movement’s leading chef, Ferran Adrià, over for a 50-course, lab-prepared meal. It was a lot to digest, sure, but what does a feast like this mean for the future of eating?